Responsabilities
- Investigation of vigilance cases by telephone/mail
- Pre-analysis of complex cases before entry
- Entry of vigilance cases in ad hoc databases or in formats defined with the client
- Medical evaluation of files on : coding (according to applicable dictionary), causal relationship between the effects and the intake of suspect products (according to applicable method), the expected/listed or unlisted nature of the events/effects/incidents, the severity of the events/effects/incidents and the case
- Identification of submission requirements for each case
- validation of certain documents produced by the data manager / medical information assistant / documentalist : letters, telephone call forms, etc.
- Closing of vigilance files
- Identification of requirements in terms of preparation of ICSR/MLM filters
- Having the responsibility of LOCAL PV and/or Qualified Person Responsible for Pharmacovigilance
- Support the Medical Information department from time to time (on-call in the evening and on weekends)